Development and external validation of Indian population-specific Garbhini-GA2 model for estimating gestational age in second and third trimesters.

Background: A large proportion of pregnant women in lower and middle-income countries (LMIC) seek their first antenatal care after 14 weeks of gestation. While the last menstrual period (LMP) is still the most prevalent method of determining gestational age (GA), ultrasound-based foetal biometry is considered more accurate in the second and third trimesters. In LMIC settings, the Hadlock formula, originally developed using data from a small Caucasian population, is widely used for estimating GA and foetal weight worldwide as the pre-programmed formula in ultrasound machines. This approach can lead to inaccuracies when estimating GA in a diverse population. Therefore, this study aimed to develop a population-specific model for estimating GA in the late trimesters that was as accurate as the GA estimation in the first trimester, using data from GARBH-Ini, a pregnancy cohort in a North Indian district hospital, and subsequently validate the model in an independent cohort in South India. Methods: Data obtained by longitudinal ultrasonography across all trimesters of pregnancy was used to develop and validate GA models for the second and third trimesters. The gold standard for GA estimation in the first trimester was determined using ultrasonography. The Garbhini-GA2, a polynomial regression model, was developed using the genetic algorithm-based method, showcasing the best performance among the models considered. This model incorporated three of the five routinely measured ultrasonographic parameters during the second and third trimesters. To assess its performance, the Garbhini-GA2 model was compared against the Hadlock and INTERGROWTH-21st models using both the TEST set (N = 1493) from the GARBH-Ini cohort and an independent VALIDATION dataset (N = 948) from the Christian Medical College (CMC), Vellore cohort. Evaluation metrics, including root-mean-squared error, bias, and preterm birth (PTB) rates, were utilised to comprehensively assess the model's accuracy and reliability. Findings: With first trimester GA dating as the baseline, Garbhini-GA2 reduced the GA estimation median error by more than three times compared to the Hadlock formula. Further, the PTB rate estimated using Garbhini-GA2 was more accurate when compared to the INTERGROWTH-21st and Hadlock formulae, which overestimated the rate by 22.47% and 58.91%, respectively. Interpretation: The Garbhini-GA2 is the first late-trimester GA estimation model to be developed and validated using Indian population data. Its higher accuracy in GA estimation, comparable to GA estimation in the first trimester and PTB classification, underscores the significance of deploying population-specific GA formulae to enhance antenatal care. Funding: The GARBH-Ini cohort study was funded by the Department of Biotechnology, Government of India (BT/PR9983/MED/97/194/2013). The ultrasound repository was partly supported by the Grand Challenges India-All Children Thriving Program, Biotechnology Industry Research Assistance Council, Department of Biotechnology, Government of India (BIRAC/GCI/0115/03/14-ACT). The research reported in this publication was made possible by a grant (BT/kiData0394/06/18) from the Grand Challenges India at Biotechnology Industry Research Assistance Council (BIRAC), an operating division jointly supported by DBT-BMGF-BIRAC. The external validation study at CMC Vellore was partly supported by a grant (BT/kiData0394/06/18) from the Grand Challenges India at Biotechnology Industry Research Assistance Council (BIRAC), an operating division jointly supported by DBT-BMGF-BIRAC and by Exploratory Research Grant (SB/20-21/0602/BT/RBCX/008481) from Robert Bosch Centre for Data Science and Artificial Intelligence (RBCDSAI), IIT Madras. An alum endowment from Prakash Arunachalam (BIO/18-19/304/ALUM/KARH) partly funded this study at the Centre for Integrative Biology and Systems Medicine, IIT Madras.

Late-Preterm Antenatal Steroids for Reduction of Neonatal Respiratory Complications: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the efficacy of antenatal corticosteroids in reducing neonatal respiratory complications when administered to those at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. METHODS: This was a single-center, triple-blind, randomized, placebo-controlled trial in southern India enrolling pregnant participants at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. Computer-generated block randomization was used with participants randomized to either one course of intramuscular betamethasone or placebo. The primary outcome was a composite of treatment for respiratory distress in the neonate, defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life. Neonatal secondary outcomes were transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, hypoglycemia, stillbirth, and early neonatal death; maternal secondary outcomes were chorioamnionitis, postpartum hemorrhage, puerperal fever, and length of hospitalization. All analyses were based on intention to treat. A sample size of 1,200 was planned with 80% power to detect a 30% reduction in rates of respiratory distress. After a planned interim analysis, enrollment was stopped for futility. RESULTS: From March 2020 to August 2022, 847 participants were recruited, with 423 participants randomized to betamethasone and 424 participants randomized to placebo. There were 22 individuals lost to follow-up. There was no statistically significant difference in the primary outcome (betamethasone 4.9% vs placebo 4.8%, relative risk 1.03, 95% CI, 0.57-1.84, number needed to treat 786). There were no statistically significant differences in secondary neonatal or maternal outcomes. CONCLUSION: Betamethasone administered in the late-preterm period to those at risk for preterm delivery did not reduce the need for treatment of neonatal respiratory distress. CLINICAL TRIAL REGISTRATION: Clinical Trials Registry of India, CTRI/2019/09/021321.

The efficacy and safety of 25 µg or 50 µg oral misoprostol versus 25 µg vaginal misoprostol given at 4- or 6-hourly intervals for induction of labour in women at or beyond term with live singleton pregnancies: A systematic review and meta-analysis.

BACKGROUND: Misoprostol is widely used for cervical ripening and labour induction as it is heat-stable and inexpensive. Oral misoprostol 25 µg given 2-hourly is recommended over vaginal misoprostol 25 µg given 6-hourly, but the need for 2-hourly fetal monitoring makes oral misoprostol impractical for routine use in high-volume obstetric units in resource-constrained settings. OBJECTIVES: To compare the efficacy and safety of oral misoprostol initiated at 25 or 50 µg versus 25 µg vaginal misoprostol given at 4- to 6-hourly intervals for labor induction in women at or beyond term (≥ 37 weeks) with a single viable fetus and an unscarred uterus. SEARCH STRATEGY: We identified eligible randomized, parallel-group, labor-induction trials from recent systematic reviews. We additionally searched PubMed, Cochrane CENTRAL, Epistemonikos, and clinical trials registries from February 1, 2020 to December 31, 2022 without language restrictions. Database-specific keywords for cervical priming, labor induction, and misoprostol were used. SELECTION CRITERIA: We excluded labor-induction trials exclusively in women with ruptured membranes, in the third trimester, and those that initiated misoprostol at doses not specified in the review's objectives. The primary outcomes were vaginal birth within 24 h, cesarean section, perinatal mortality, neonatal morbidity, and maternal morbidity. The secondary outcomes were uterine hyperstimulation with fetal heart rate changes, and oxytocin augmentation. DATA COLLECTION AND ANALYSIS: Two or more authors selected studies independently, assessed risk of bias, and extracted data. We derived pooled weighted risk ratios with 95% confidence intervals (CIs) for each outcome, subgrouping trials by the dose and frequency of misoprostol regimens. We used the I2 statistic to quantify heterogeneity and the random-effects model for meta-analysis when appropriate. We used the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach to assess certainty (confidence) in the effect estimates. MAIN RESULTS: Thirteen trials, from Canada, India, Iran, and the US, randomizing 2941 women at ≥37 weeks of gestation with an unfavorable cervix (Bishop score <6), met the eligibility criteria. Five misoprostol regimens were compared: 25 µg oral versus 25 µg vaginal, 4-hourly (three trials); 50 µg oral versus 25 µg vaginal, 4-hourly (five trials); 50 µg followed by 100 µg oral versus 25 µg vaginal, 4-hourly (two trials); 50 µg oral, 4-hourly versus 25 µg vaginal, 6-hourly (one trial); and 50 µg oral versus 25 µg vaginal, 6-hourly (two trials). The overall certainty in the evidence ranged from moderate to very low, due to high risk of bias in 11/13 trials (affecting all outcomes), unexplained heterogeneity (1/7 outcomes), indirectness (1/7 outcomes), and imprecision (4/7 outcomes). Vaginal misoprostol probably increased vaginal deliveries within 24 h compared with oral misoprostol (risk ratio [RR] 0.82, 95% CI 0.70-0.96; 11 trials, 2721 mothers; moderate-certainty evidence); this was more likely with 4-hourly than with 6-hourly vaginal regimens. The risk of cesarean sections did not appreciably differ (RR 1.00, 95% CI 0.80-1.26; 13 trials, 2941 mothers; very low-certainty evidence), although oral misoprostol 25 µg 4-hourly probably increased this risk compared with 25 µg vaginal misoprostol 4-hourly (RR 1.69, 95% CI 1.21-2.36; three trials, 515 mothers). The risk of perinatal mortality (RR 0.67, 95% CI 0.11-3.90; one trial, 196 participants; very low-certainty evidence), neonatal morbidity (RR 0.84, 95% CI 0.67-1.06; 13 trials, 2941 mothers; low-certainty evidence), and maternal morbidity (RR 0.83, 95% CI 0.48-1.44; 6 trials; 1945 mothers; moderate-certainty evidence) did not differ appreciably. The risk of uterine hyperstimulation with fetal heart rate changes may be lower with oral misoprostol (RR 0.70, 95% CI 0.52-0.95; 10 trials, 2565 mothers; low-certainty evidence). Oxytocin augmentation was probably more frequent with oral compared with vaginal misoprostol (RR 1.29, 95% CI 1.10-1.51; 13 trials, 2941 mothers; moderate-certainty evidence). CONCLUSIONS: Low-dose, 4- to 6-hourly vaginal misoprostol regimens probably result in more vaginal births within 24 h and less frequent oxytocin use compared with low-dose, 4- to 6-hourly, oral misoprostol regimens. Vaginal misoprostol may increase the risk of uterine hyperstimulation with fetal heart changes compared with oral misoprostol, without increasing the risk of perinatal mortality, neonatal morbidity, or maternal morbidity. Indirect evidence indicates that 25 µg vaginal misoprostol 4-hourly may be more effective and as safe as the recommended 6-hourly vaginal regimen. This evidence could inform clinical decisions in high-volume obstetric units in resource-constrained settings.

C- reactive protein levels in women with prelabour rupture of membrane and women with normal labour.

Background: There is a very little information known about CRP in term pregnancies. It is a marker that is easily tested and is inexpensive. Although CRP has been used very effectively in diagnosing infection in the neonate, its clinical use and values have not been studied in term pregnancies. The level of CRP that is truly normal or clinically innocuous is not known. Objectives: This is a cross-sectional study to compare the CRP levels in antenatal women with PROM and women with normal labor and assess its utility to predict sepsis. Methods: This is a prospective study done over a period of one year and approved by the insititutional ethical committee (IRB. Min. No 11102[OBSERVE] dated 10.01.2018). Sample for CRP was collected from 112 antenatal women with prelabor rupture of membranes within 12 hours of admission (Group A) and from 112 antenatal women in spontaneous labor without rupture of membrane (Group B). CRP samples are processed by nephelometry method. Results: The median CRP value in Group A is 9.15 and Group B is 7.26, with no statistical difference. Chorioamnionitis, neonatal sepsis, and endometritis were similar in both the groups. Conclusion: CRP cannot be used as predictor for chorioamnionitis, endometritis, and neonatal sepsis. There was no significant difference in CRP levels between the two groups.

Is new onset hypertension in obese women more likely to be Gestational Hypertension? - A retrospective study.

Introduction: New onset hypertension is more common in antenatal women with increased Body Mass Index (BMI). This may be due to either gestational hypertension (GH) or pre-eclampsia (PE). GH unlike PE is not associated with poor perinatal outcomes and would not require interventions such as increased antenatal visits and induction of labour. Our study assessed the prevalence of GH and PE in women with increased BMI as compared to women with normal BMI. Setting and Design: Historical cohort of a large tertiary centre. Method and Materials: Data from the electronic birth registry of the labour room was used to identify women who had a BMI ≥ 35 kg/m2 at delivery. Women with a normal BMI matched for the mode of delivery was taken as control. 148 women with BMI ≥ 35 kg/m2 were compared with 140 women of normal BMI. Results: New onset hypertension was seen in 41.2% (61/148) and 8.6% (12/140) in the non-obese group RR 4.81 (2.7-8.54) P (<0.001). GH was seen in 24.3% in obese women and 2.9% in normal controls, RR (9.65 (3.54,26.34)), P (<0.001). PE was seen in 16.9% of obese women and 5.7% of women with normal BMI, RR (3.79 (1.78,8.08)) P (<0.001). Proportion of GH in women with new onset hypertension was seen in 59% of obese women with new onset hypertension and 33% of normal controls. Conclusion: This clinically relevant trend towards an increased proportion of GH highlights the importance of identifying pathophysiological mechanism for high BP in obesity when there is new onset hypertension.

Placental chorioangioma with an emphasis on rare giant placental chorioangioma and associated maternal and perinatal outcome: Clinicopathological study in a single centre.

Context: Giant placental chorioangiomas (GPC) are exceedingly rare and harbour potential to cause feto-maternal complications with resultant morbidity. Aims & Materials and Methods: A retrospective study using details from Department of Obstetrics & Gynaecology and Pathology is done to study the various clinical and pathological features of placental chorioangiomas with a special emphasis on the rare GPCs and associated complications. Results: Over a period of 16 years, 20 cases were diagnosed as chorioangioma in our institution. 60% of these occurred in primigravida (n=12) and 71% cases carried a female foetus. Only 25% cases were > 30 years. Maternal and foetal complications occurred in 85% and 50% cases. Pre-term labour was the common maternal complication and foetal death/stillbirth was the most common foetal complication. There were 15 cases of GPC, 73% occurred in primigravida (n=11) and 75% of cases carried a female foetus. There were no cases of maternal death or recurrence. Primigravidity was associated with maternal complication in contrast to multigravidity (P = 0.049). Mean age of mothers with maternal complications and those without maternal complications reached statistical significance (P = 0.001). Though histologically all the cases were similar, calcification and infarction were seen exclusively in GPC cases. Conclusion: GPCs are rare and our data adds evidence to use 4cm as an optimum cut-off in the definition. GPCs were associated with a high percentage of primigravidity, female foetus, and poorer outcome of pregnancy. Routine examination of placenta in unexplained foetal/perinatal demise must be stressed to detect microscopic evidence of chorioangioma.

Study protocol: 'a large cohort study of postnatal events in a not-for-profit referral centre in Vellore, South India'.

INTRODUCTION: In a large developing country, with diverse population characteristics and differential access to healthcare, it is important to identify factors that influence postnatal health. This knowledge will help frame recommendations to enhance universal postnatal care. METHODS AND ANALYSIS: A prospective cohort study will be conducted by recruiting all participants who deliver in a referral centre in South India during a 1-year period after written consent is obtained from them. In addition to clinical information pertaining to their delivery and demographics, details of physical health, mental health socioeconomic status and emotional support will also be collected. Every participant will be followed up physically and/or by telephonic consultation at 3, 9 and 18 months of their postnatal period to reassess their status and that of their babies. As there are several independent and dependent variables requiring multivariate analysis, a sample size of 10 000 is considered adequate. Any unplanned visits to a health facility will be enquired into and documented for analysis.During data analysis, the effect of Caesarean section, high-risk characteristics and gestational age of the baby at delivery on various outcome measures and postnatal status will be evaluated. Interpretation of the large volume of collected data will help frame recommendations to improve postnatal care ETHICS AND DISSEMINATION: The study is approved by the Institutional Review Boards (Research and Ethics Committees) of Christian Medical College, Vellore, Tamil Nadu, India (IRB 12178 date 24 June 2020).Women are provided with a detailed information sheet and written consent is obtained. They are reassured that their care will not be compromised if they do not consent to the study. Data will be available on the clinical trial portal to assist in the dissemination of results after the project is published. TRIAL REGISTRATION NUMBER: CTRI/2022/03/041343.

The Impact of Secondary Hypertension in Pregnancy on Maternal and Fetal Outcomes: A 42-Month Observational Study from South India.

Objectives: To examine the prevalence, etiology, and clinical outcomes of secondary hypertension in pregnancy in a high-risk tertiary care hospital. Study Design: This retrospective study used data from patient records between January 2015 and July 2018. Of 52,293 pregnant women admitted during this period, those with hypertension were included. Patient demographics, diagnosis of secondary hypertension, investigations, suspected etiologies of secondary hypertension, maternal and neonatal outcomes and discharge conditions were included. Main Outcome Measures: The prevalence of secondary hypertension and causes were measured. Univariate followed by multivariate analyses were done to look for associated maternal and neonatal outcomes. Results: Among patients with chronic hypertension in pregnancy, 13.7% had secondary causes, of which renal and cardiac causes were the commonest. The incidence of severe pre-eclampsia (40.5%) among patients with secondary hypertension was higher in patients with systolic blood pressures more than 140 mm of Hg than in those with systolic blood pressures lower than 140 mm of Hg (odds ratio [OR]: 4.92, confidence interval [CI]: 1.7-14.16, p: 0.002) irrespective of etiology. Pre-eclampsia predisposed to maternal acute kidney injury (OR: 1.23, CI: 1.04-1.45, p: 0.003), low birthweight (OR: 4.69, CI: 1.44-11.9, p: 0.006), preterm delivery (OR: 4.69, CI: 1.78-12.34, p: 0.001), and neonatal death (OR: 5.19, CI: 0.97-27.6, p: 0.04). Conclusion: The prevalence of hypertension in pregnancy was 10.3%; among them, the prevalence of secondary hypertension was 1.46%. Uncontrolled secondary hypertension was associated with poor maternal and neonatal outcomes. Strict control of blood pressure in secondary hypertension in pregnancy ensured better outcomes.

Maternal and neonatal outcomes in extra hepatic portal vein obstruction: Our experience.

BACKGROUND: Women with Extra hepatic portal vein obstruction (EHPVO) are mostly young and belong to Asian countries. In the Indian subcontinent, 20-30% variceal bleeds are caused by EHPVO. Hence pregnancy is a concern in such patients. The objective of this study is to observe the maternal and neonatal outcomes in women with EHPVO. MATERIALS AND METHOD: Extra hepatic portal vein obstruction was studied retrospectively in 28 pregnancies in 20 women from Jan 2011 to July 2018 at a tertiary hospital in South India and the pregnancy outcomes were observed during this period. Institutional Review Board approval obtained. RESULTS: The mean age of the women was 24.3 years and the mean age of diagnosis was 18.5 years. Splenomegaly, thrombocytopenia and anaemia were seen in 22 (78.5%), 17 (60.7%) and 8 (28.5%) of pregnancies, respectively. Rate of abortions and preterm deliveries were 2 (7.1%, n =28) and 10 (35.7%, n =28). There was one stillbirth (3.6%) in the study group. EHPVO was diagnosed in 25 (89.3%) women prenatally in our series. During pregnancy only one woman had variceal bleed, which was managed conservatively. Blood and blood product transfusion was required in 7(25%) of women and there was no maternal mortality. CONCLUSION: Pregnancies in EHPVO have good maternal and neonatal outcomes, provided they are taken care of by a multidisciplinary approach in a tertiary care centre.

Efficacy of Antenatal Ultrasound Examination in Diagnosis of Congenital Cardiac Anomalies in an Unselected Population: Retrospective Study from a Tertiary Centre.

BACKGROUND: In Low- and Middle-Income Countries like India, where the services and surgical care for Congenital Heart Disease (CHD) are available only in selected centres with geographical variations, it is important to detect Heart defects early and give the parents an opportunity to plan ahead for seeking appropriate care at the earliest. Several developments in recent years such as improvement of quality of ultrasound machines, sonographer's experience, skills and better description of cardiac views have contributed to improve detection rate. METHODS: A retrospective study was done between March 2016 and December 2019, and showed ultrasound evidence of CHD was included. RESULTS: The total number of morphology scans done during study period was 50,435. The number of congenital anomalies detected was 1482, out of which CHD was detected in 334 (22.5%). Outcome of 50 pregnancies were not available while the rest (284) were available for follow up in post-natal period. There were 51 cases of CHD, missed on routine antenatal morphological screening, which were diagnosed in the post-natal period. There were 18 cases of over-diagnosed CHD on antenatal scan, but were found to have normal echo findings after birth. CONCLUSION: A systematic approach is crucial for practitioner to determine the patterns of associated defects. Use of step wise strategy helps in determining the correct diagnosis of isolated cardiac defect, associated with other system or a part of syndrome. Systematic audit of morphological scans could play an important role in improving the diagnostic accuracy, which in turn will lead to early detection.

Update on pregnancy in Takayasu arteritis-A narrative review.

Takayasu arteritis (TA) is a chronic, idiopathic large-vessel vasculitis that affects women of reproductive age, and has significant maternal and fetal implications. Although there are contrasting data on the effect of TA on fertility, most studies have shown that fertility outcomes remain unaffected. The disease activity of TA usually either remains stable or decreases during pregnancy. The important fetomaternal complications are maternal hypertension, pre-eclampsia, prematurity, and intrauterine growth restriction. To reduce maternal and fetal morbidity, controlling the disease before conception is important. This review article discusses the various implications, challenges, and medical and endovascular management of TA during pregnancy.

Peripartum cardiomyopathy: An analysis of clinical profiles and outcomes from a tertiary care centre in southern India.

Peripartum cardiomyopathy is a syndrome of maternal heart failure with decreased left ventricular ejection fraction affecting maternal and fetal well-being. We analysed clinical profiles and outcomes in women with peripartum cardiomyopathy enrolled retrospectively from a tertiary care centre in southern India (1 January 2008-31 December 2014). The incidence of peripartum cardiomyopathy was one case per 1541 live births. Fifty-four women with a mean age of 25.5 years and mean gestational age of 35.4 weeks were recruited; 35 were primigravidae. Maternal and fetal deaths occurred in 9.3% and 24.1% of subjects, respectively. Mild-to-moderate maternal anaemia (80-110 g/L) was associated with fetal mortality (p = 0.02). Reduced left ventricular ejection fraction (<30%, p = 0.04) and cardiogenic shock (p = 0.01) were significantly associated with adverse maternal outcomes. Forty per cent of women were followed up after 24.2 ± 17.7 months, and in these women a significant increase in left ventricular ejection fraction was seen (mean 16.4%, p < 0.01); all were asymptomatic. Peripartum cardiomyopathy with poor left ventricular ejection fraction and shock is associated with adverse maternal outcomes, while non-severe maternal anaemia predisposes to adverse fetal outcomes. Significant left ventricular ejection fraction recovery occurred on follow-up.

Expectant versus immediate delivery in women with PPROM between 34 and 35+6 weeks: A Retrospective cohort.

CONTEXT: Studies comparing the efficacy of expectant management (EM) and immediate delivery (ID) in the management of women with preterm prelabor rupture of membranes (PPROM) between 34 and 35+6 weeks have not been done in a developing country. Although large multicentric studies show better outcomes with EM, the economic implications have not been studied. AIMS: This study compared women with PPROM between 34 and 35 +6 weeks, managed expectantly with women who were delivered immediately. SETTINGS AND DESIGN: Large tertiary center and retrospective cohort. METHODS AND MATERIALS: Data of 206 women with PPROM between 34 and 35+6 weeks managed with immediate delivery in the years 2014 and 2015 were compared with seventy-five women with PPROM managed expectantly in the years 2016 and 2017. STATISTICAL ANALYSIS USED: Data was summarized using mean standard deviation (SD) or median interquartile range for continuous variables and frequency and percentage for categorical variables. Continuous variables were compared using independent t-test and categorical variables were compared using Chi-square statistics. RESULTS: Neonatal sepsis was seen in 1/75 (1.3%) in the group managed expectantly and 12/206 (5.8%) in the ID group (P = 0.109). Respiratory distress was seen in 3/75 (4%) in the group managed expectantly and 22/206 (10.7%) with ID (P = 0.08). Chorioamnionitis was similar in both groups. Cesarean rate was 17.3% with expectant management and 28% with ID (P = 0.065). The mean hospital bill was ₹.33,494/- in the ED group and ₹.27,079/- in the ID group (P < 0.001). CONCLUSIONS: Expectant management was more expensive.

Enzyme-linked immunosorbent assay (ELISA) versus Venereal Disease Research Laboratory test (VDRL) and rapid plasma reagin test (RPR) for screening of syphilis in pregnant women.

OBJECTIVE: To evaluate a treponemal enzyme-linked immunosorbent assay (ELISA) as an alternative screening test for syphilis in pregnant women. METHODS: A cross-sectional study of diagnostic test accuracy was carried out in a large volume laboratory from a tertiary care center. A total of 416 serum samples, including 102 archived syphilis Treponema pallidum hemagglutination (TPHA)-positive samples and 314 samples from pregnant women, were used to determine the sensitivity and specificity of ELISA. All the samples were subjected to Venereal Disease Research Laboratory (VDRL), rapid plasma reagin (RPR), ELISA, and TPHA tests. Performance characteristics of VDRL, RPR, and ELISA were calculated with TPHA as a reference standard test. RESULTS: VDRL and RPR exhibited higher false positivity of 10.5% and 9.6%, respectively, compared to 2.5% by ELISA. The sensitivity and specificity of ELISA were 98% and 97.5%, of VDRL were 71.6% and 89.5%, and of RPR were 73.5% and 90.5%, respectively. Moreover, ELISA had an excellent agreement (kappa=0.9) with TPHA compared to VDRL/RPR which had a moderate agreement (kappa=0.6) only. CONCLUSION: ELISA has the potential to replace VDRL/RPR as a screening test for syphilis in centers that can perform ELISA, especially for antenatal screening.

A prospective observational study of the follow-up of medical management of early pregnancy failure.

BACKGROUND: Medical termination for missed miscarriage with the use of 800 µg of vaginal misoprostol as a single agent is recommended as a cheap option before 14 weeks of gestation in developing countries. A few studies have looked at its efficacy. METHODS: A prospective, observational study was done on women having medical termination with up to three doses of 800 µg vaginal misoprostol at 12 hourly intervals. The number of women who needed check curettage was collected. Ultrasound findings if done were collated. Follow-up was done telephonically at the end of first week, fourth week and sixth week. RESULTS: The cohort comprised 145 women. The primary outcome was the need for curettage after expulsion of products following medical management and this was 49/145 (37.8%) of women. The induction expulsion interval was 36 hours. The mean endometrial thickness of the 113/145 women who had an ultrasound was 11 mm. The mean endometrial thickness in women who had check curettage was 18 mm. Persistent spotting was the only significant symptom at follow-up. Resumption of cycle at the end of the sixth week was seen in 105/132 (80.15%) of women who were followed up. CONCLUSION: Findings of our study showed the check curettage rate of 37.8%. However, the regime which we used, that is, 800 µg vaginal misoprostol at 12 hourly intervals had a long induction to expulsion interval of 36 hours. In all, 80% of women resumed normal cycles at the end of the sixth week. No significant complications were noted on follow-up.

Randomized controlled trial of the effect of amniotomy on the duration of spontaneous labor.

OBJECTIVE: To investigate the effect of amniotomy on the duration of spontaneous labor. METHODS: In the present randomized controlled trial, women in spontaneous labor with singleton pregnancies presenting at a tertiary teaching hospital in South India between August 1, 2014, and October 31, 2015, were randomized in a 1:1 ratio to undergo amniotomy or conservative management. The primary outcome was the duration of labor. Per-protocol analyses were performed and the duration of labor was compared between the groups of patients. RESULTS: There were 144 patients randomized to each group. The median duration of labor was 235 minutes (interquartile range 117-355) in the amniotomy group and 364 minutes (interquartile range 201-580) in the conservative management group (P<0.001). CONCLUSION: Amniotomy was associated with a shorter duration of labor in comparison with conservative management in patients with singleton pregnancies experiencing spontaneous labor. Clinical Trials Registry-India: (CTRI) (CTRI/2014/12/005264).

Digital stretching of cervix in the active phase of labour to shorten its duration: a randomised control trial.

An assessment of the efficacy and satisfaction of women in active labour having digital cervical stretching compared to women who did not have this intervention. Ours was a randomised controlled trial at a tertiary centre in India. Low-risk women at term with vertex presentation in active labour with ruptured membranes and cervical dilation of 4-6 cm were included. Stretching to delivery interval was 247.5 ± 158.2 min in the intervention group and 265.5 ± 158.4 in the control group. The mode of delivery, incidence of cervical tear, and maternal, fetal and neonatal complications were similar in both groups. The Labour and Delivery Satisfaction Index (LADSI) was similar in both groups. While no significant discomfort was perceived with stretching, it does not appear to expedite labour.

Randomized double-blind placebo controlled study of preinduction cervical priming with 25 µg of misoprostol in the outpatient setting to prevent formal induction of labour.

OBJECTIVE: To compare the efficacy of preinduction outpatient use of a single dose of 25 µg vaginal misoprostol between 381/2 and 40 weeks with that of placebo, to decrease the interval from intervention to delivery after stretch and sweep in low-risk gravid women with Bishop's score <4. METHOD: Sixty three women received 25 µg vaginal misoprostol and 63 women received placebo after stretch and sweep. RESULTS: The duration from intervention to delivery was 3.35 (1.12-9.46) days in the misoprostol group and 5.42 (2.39-10.11) days in the placebo group which was statistically significant (p = 0.029). Spontaneous labor was seen in 39 women (61.9 %) in the misoprostol group and 35 women (55.6 %) in the placebo group (p = 0.531). Eight women in the misoprostol group and 18 in the placebo group had Lower Segment Caesarean Section (LSCS) and this difference was also statistically significant (p = 0.027). There were no major maternal and neonatal complications in both groups. CONCLUSION: Preinduction use of 25 µg vaginal misoprostol after stretch and sweep in the outpatient setting decreased the intervention to delivery interval when compared to placebo.

A randomised controlled trial comparing 30 mL and 80 mL in Foley catheter for induction of labour after previous Caesarean section.

Inducing labour with a Foley balloon catheter rather than using oxytocin or prostaglandins is considered to be less risky if the uterus is scarred.1 It is not known if more fluid in the balloon is more effective without being more dangerous. Volumes of 80 mL and 30 mL were compared in 154 eligible women. Mode of delivery, duration of labour and delivery within 24 h were similar in both groups. However, the second group required oxytocin more frequently. Though more scar dehiscences occurred in the first group, the difference was not significant.